Business Wire

SpeeDx Receives Clearance from Health Canada for ResistancePlus® MG Test

Share

SpeeDx Pty. Ltd. today announced Resistance Plus® MG has been cleared by Health Canada and is now available for sale across all Canadian provinces (not currently available in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen, along with genetic markers linked to antibiotic resistance. This is the first commercially available test in Canada combining identification and therapeutic guidance information to support Resistance Guided Therapy for management of Mgen.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190715005544/en/

(Photo: Business Wire)

(Photo: Business Wire)

Current Canadian management guidelines for Mgen direct laboratories to forward positive samples to the National Microbiology Laboratory for resistance testing.1 Now Canadian laboratories can utilize Resistance Plus MG and bring this service inhouse to generate more timely results for doctors and their patients.

"SpeeDx tests are designed to empower clinicians to make informed treatment decisions,” said Colin Denver, SpeeDx CEO. “Bringing Resistance Plus MG to Canada allows even more clinicians to access Resistance Guided Therapy, helping to improve patient cure rates and reduce overall health care costs.”

Resistance to azithromycin, a commonly recommended treatment for Mgen infection, has been rising where empiric treatment or Mgen detection only practices have predominated.2 A groundbreaking paper using Resistance Plus MG as part of a Resistance Guided Therapy protocol reported significant success - improving cure rates from below 60% to over 92%.2 Resistance Plus MG is already in use across Europe, U.K., Australia, and New Zealand, where recent STI management guideline updates recommend assessing the resistance status of Mgen infections in order to guide appropriate treatment.3-5

There is not currently a U.S. Food and Drug Administration (FDA) -cleared commercially available test for the combined detection of M. genitalium and macrolide resistance markers. SpeeDx is finalizing clinical trials across the U.S. in preparation for FDA submission later this year. The FDA also recently granted breakthrough status for the SpeeDx Resistance Plus® GC test, supporting Resistance Guided Therapy for gonorrhea infections.6 Resistance Plus GC provides information on ciprofloxacin susceptibility/resistance, giving doctors and patients the option of using ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant gonorrhoea infections.

“Our Resistance Plus tests represent a new way of using diagnostics, providing more information on the infecting organism,” adds Denver. “The availability of this kind of testing has now influenced Mgen treatment guidelines around the world and we are delighted with this new registration for Canada as well as the prospect of offering this and other similar tests in the U.S. market in the near future.”

About M. genitalium (Mgen)

M. genitalium is a STI that can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than gonorrhea.7 Like Neisseria gonorrhoeae, Mgen is also evolving into a so-called STI superbug that is becoming resistant to many antibiotic treatments leading to exceedingly difficult to treat infections and threatening global public health.8 Macrolide antibiotics, specifically azithromycin, are the first-line treatment but resistance to these antibiotics has increased.1,9,10 Due to this growing antibiotic resistance problem, several global STI Management Guidelines on Mgen infections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.2-4

About SpeeDx

SpeeDx has developed a molecular diagnostics test portfolio for infectious diseases that provides identification of infecting organism and therapeutic guidance capabilities. The company is based in Australia with offices in Austin and London, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Innovative real-time polymerase chain reaction (qPCR) technology has driven market-leading multiplex detection and priming strategies. Product portfolios focus on multiplex diagnostics for sexually transmitted infections (STIs), antibiotic resistance markers, and respiratory disease. For more information about SpeeDx please see: https://plexpcr.com

  1. https://www.canada.ca/en/public-health/services/infectious-diseases/sexual-health-sexually-transmitted-infections/canadian-guidelines/sexually-transmitted-infections/canadian-guidelines-sexually-transmitted-infections-49.html
  2. Read T R H, et al. CID 2019; 68(4):554-560
  3. https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
  4. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
  5. Jensen JS, et al. 2016.PMID: 27505296.
  6. https://www.businesswire.com/news/home/20190611005313/en/SpeeDx-Receives-FDA-Breakthrough-Designation-ResistancePlus%C2%AE-GC
  7. Miller WC et al. JAMA 2004; 291:2229–2236.
  8. Unemo M & Jensen JS. Nat Rev Urol. 2017; 14:139-152.
  9. Getman D et al. J Clin Micro 2016; 54:2278-2283.
  10. Murray GL et al. Emerg Infect Dis 2017; 23(5):809-812.

Contact information

Europe, Australia, New Zealand
Madeline O’Donoghue
madelineo@speedx.com.au
+61 2 9209 4170

Rick Roose
roi.roose@gmail.com
+1.415.202.4445
United States

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

c-LEcta: Successful Product Business in the First Half of 201922.8.2019 11:06:00 EESTPress release

c-LEcta, a globally active biotechnology company with technology leadership in enzyme engineering and bioprocess development, successfully expanded its product business in the first half of 2019. Besides sales increases across the entire portfolio, the company was granted many new patents. While the patent portfolio still comprised 59 granted patents at the end of the first half of 2018, the Leipzig-based company now holds more than 80 patents. c-LEcta’s DENARASE®, which is used for the necessary removal of nucleic acids from biopharmaceutical products, performed particularly well. DENARASE® is the most efficient technology on the market for meeting the stringent regulatory requirements for biopharmaceutical products. Sales of this product increased by 164% year-on-year in the first half of 2019. The other products in c-LEcta’s portfolio also performed very well and contributed to the positive development of the product business. c-LEcta now markets its self-developed products in 25 co

MobileIron Named a Leader Again in the Second Gartner Magic Quadrant for Unified Endpoint Management Tools22.8.2019 10:00:00 EESTPress release

MobileIron (NASDAQ:MOBL), the company that introduced the industry’s first mobile-centric, zero trust platform for the enterprise, today announced that it has been positioned as a Leader for the second consecutive year in the Gartner Magic Quadrant for Unified Endpoint Management Tools. The report evaluated 11 vendors based on completeness of vision and ability to execute. “To us, it’s an honor to be recognized once again as a Leader in Gartner’s Magic Quadrant for Unified Endpoint Management Tools,” said Simon Biddiscombe, CEO, MobileIron. “We have continued to innovate and expand upon our UEM platform to keep up with the demands of today’s digital businesses. Earlier this year, we introduced a revolutionary zero sign-on experience to eliminate passwords and make the world’s most ubiquitous product – the mobile device – your ID and secure access to the enterprise built on our leadership foundation in UEM. Mobile and cloud technologies have driven a dramatic change in organizations acr

Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System22.8.2019 09:00:00 EESTPress release

Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases or conditions and recognizes the novelty of the PiCSO Impulse System and its potential to benefit patients with anterior STEMI heart attacks. The Centers for Medicare & Medicaid Services (CMS) also recently acknowledged the importance of this designation by establishing an alternative reimbursement pathway for products that receive FDA marketing authorization and held the Breakthrough Designation. PiCSO therapy is provided by interventional cardiologists during PCI (Percutaneous Coronary Intervention) in patients experiencing ST-elevated myocardial infarction (STEMI). The PiCSO Impulse System clears the coronary microcirculation by intermittently

Mori Building Unveils Massive Urban Regeneration Project in Central Tokyo22.8.2019 07:00:00 EESTPress release

Mori Building Co., Ltd., a leading urban landscape developer, has begun construction on its “Toranomon-Azabudai District Category 1 Urban Redevelopment Project,” a massive urban regeneration project aimed at revitalizing a large area of central Tokyo. A groundbreaking ceremony was held on August 5 and project completion is scheduled for the end of March 2023. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190821005445/en/ Image of Office Lobby (Graphic: Business Wire) The core concept of the Toranomon-Azabudai Project is that of a “Modern Urban Village,” a unique neighborhood that will combine the sophistication of a megalopolis with the intimacy of a small village in the heart of Tokyo. It will cover an area of approximately 8.1 hectares, similar to that of New York’s Rockefeller Center, and will feature extensive greenery totaling 24,000 m2 including a 6,000 m2 central square. Total floor area will be 860,400 m2, including

Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency22.8.2019 02:01:00 EESTPress release

STRICTLY FOR EUROPEAN MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY As the European distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM). The submission is based on the results from the landmark Phase III CREDENCE study1 which evaluated the efficacy and safety of canagliflozin versus placebo in this high-risk patient population when used in addition to standard of care. “Chronic kidney disease is a serious complication of type 2 diabetes, which can increase patients’ risk of developing end-stage renal disease and may reduce their life expectancy by several years.” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma. “If approved, this licence

Triton Digital Releases Webcast Metrics Rankings for the Top Digital Audio Properties for April 201921.8.2019 23:00:00 EESTPress release

Triton Digital®, the global technology and services leader to the digital audio and podcast industry, released today its monthly Webcast Metrics® rankers for April 2019. The global rankers, in addition to the U.S., LATAM, and EMEA regional rankers provide insight into the top-performing streaming audio stations and networks around the world for the month of April. The full results of the Global & Regional Rankers for April 2019 can be found here: https://www.tritondigital.com/resources/monthly-rankers/rankers-archive The Webcast Metrics streaming measurement service is the industry standard for online audio consumption data. It provides credible, validated data that enables audio publishers around the world to analyze the consumption of their audio content by daypart, device type, geography, distribution platform, and more. About Triton Digital Triton Digital® is the global technology and services leader to the digital audio and podcast industry. Operating in more than 40 countries, Tr

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom